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Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery

Primary Purpose

Cholecystolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Madany Closure
Standard closure
Sponsored by
ClinAmygate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age . 18 years eligible for Laparoscopic cholecystectomy Exclusion Criteria: refused to participate

Sites / Locations

  • Aswan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Madany closure

Control

Arm Description

the novel port site closure technique is to be done for this group

external closure of the port site

Outcomes

Primary Outcome Measures

closure time
closure time in seconds
rate of closure failure
rate failure to close the port site

Secondary Outcome Measures

incidence of port site infection
incidence of infection of the port site
incidence of port site hernia
incidence of hernia at the port site

Full Information

First Posted
September 6, 2023
Last Updated
September 17, 2023
Sponsor
ClinAmygate
Collaborators
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06035302
Brief Title
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Official Title
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
Collaborators
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
this study aims to evaluate the effectiveness of the use of a basic laparoscopic instrument (Only needle holder) with a new technique for port site closure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Madany closure
Arm Type
Experimental
Arm Description
the novel port site closure technique is to be done for this group
Arm Title
Control
Arm Type
Active Comparator
Arm Description
external closure of the port site
Intervention Type
Procedure
Intervention Name(s)
Madany Closure
Intervention Description
Madany Closure is a new technique for the porte site closure
Intervention Type
Procedure
Intervention Name(s)
Standard closure
Intervention Description
Standard closure technique of the port site from ecternal
Primary Outcome Measure Information:
Title
closure time
Description
closure time in seconds
Time Frame
1 day
Title
rate of closure failure
Description
rate failure to close the port site
Time Frame
1 day
Secondary Outcome Measure Information:
Title
incidence of port site infection
Description
incidence of infection of the port site
Time Frame
1 month
Title
incidence of port site hernia
Description
incidence of hernia at the port site
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age . 18 years eligible for Laparoscopic cholecystectomy Exclusion Criteria: refused to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohie El-Din M Madani, MD
Phone
01141341342
Email
Mohie.madany@med.aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Emad R Issak, MSc
Phone
01066208065
Email
emangate@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madani, MD
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany, MD
Phone
01141341342
Email
Mohie.madany@med.aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany, MD

12. IPD Sharing Statement

Learn more about this trial

Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery

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